Job Title: Study Coordinator

Work Location: Monmouth County, New Jersey

Summary:

Seeking a Study Coordinator with strong multitasking abilities, a positive attitude, and a passion for advancing patient-centered cancer research. This role involves supporting clinical trials, ensuring protocol compliance, and collaborating with cross-functional teams to deliver high-quality research outcomes.

Responsibilities:

• Coordinate and manage all aspects of assigned clinical trials, including patient screening, recruitment, and enrollment using electronic systems.
• Maintain accurate and timely documentation, including enrollment logs, source documents, and data entry into EDC and EMR systems within specified timeframes.
• Schedule and follow up on patient visits, ensuring all required procedures, tests, and results are completed according to protocol.
• Monitor patient safety, report adverse events and protocol deviations promptly, and ensure compliance with regulatory and ethical guidelines.
• Oversee study drug accountability, manage study kits, and ensure proper handling, storage, and destruction of investigational products and biological specimens.
• Collaborate with multidisciplinary teams and external research entities to resolve queries, support audits, and facilitate regulatory documentation collection.
• Participate in regular study meetings, attend required training and trial-specific sessions, and provide workflow updates to the study team.
• Identify and resolve protocol-related issues, generate solutions for process improvements, and perform additional duties as assigned.

Qualifications:

• Minimum 1 year of experience with oncology interventional clinical trials.
• Certified Clinical Research Professional (ACRP CCRC/CCRA or SoCRA CCRP) with at least one year of oncology trial experience, or High School diploma with four years of oncology clinical trial experience.
• Proficient computer skills and strong interpersonal, written, and verbal communication abilities.
• Previous regulatory affairs experience is a plus.
• Available to work on-site Monday to Friday, 9 am to 5 pm.
• Experience with centrifuge operation and handling biofluid specimens preferred.
• Demonstrated ability to multi-task, prioritize, and manage time effectively in a fast-paced environment.

Published Category: Clinical Operations & Development